Methods of respiratory enhancement using a dental appliance

ABSTRACT

A dental appliance apparatus is disclosed herein. In various aspects, the dental appliance may include a body removably attachable to one or more teeth selected from premolars and molars, and a flange extending forth from lingual portions of the body to contact a tongue at one or more locations proximate the premolars and the molars in order to cause a contraction of the genioglossus that positions the tongue anteriorly and downward toward the mandible by stimulation of the hypoglossal nerve. The dental appliance may include a connector connected to the body, and the connector may pass about buccal-labial sides of the anterior teeth. A bumper may be included on a labial side of the connector, and the bumper may contact the lips to promote pursed lips breathing. An anterior flange may extend lingually from the connector to stimulate the hypoglossal nerve proximate a tip of the tongue in order to cause contraction of the genioglossus to position the tongue anteriorly and downward toward the mandible.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present Application is a continuation of co-pending U.S. patentapplication Ser. No. 16/406,324 filed 8 May 2019 that, in turn, is acontinuation of U.S. patent application Ser. No. 14/993,198 filed 12Jan. 2016 (now U.S. Pat. No. 10,328,225) that claims priority andbenefit of U.S. Provisional Patent Application No. 62/244,107 filed 20Oct. 2015, all of which are hereby incorporated by reference in theirentireties herein.

BACKGROUND OF THE INVENTION Field

The present disclosure relates to dental appliances, and, in particular,to dental appliances that may enhance respiratory performance, forexample, during physical activity.

Background

During engagement in a physical activity, the human body utilizes threepathways to create energy in the form of adenosine triphosphate (ATP).The body utilizes a mixture of both fats and carbohydrates to make ATP,with some minimal contributions from protein. However, despite theabundance of fat, the human body will fatigue during physical activity.One common cause of fatigue is the build-up of lactic acid, specificallythe hydrogen ions associated with lactic acid build-up that interferewith producing ATP. Thus, reducing lactic acid build-up may reducefatigue by reducing interference with the production of ATP, which may,for example, improve performance by increasing the duration or intensityof engagement in the physical activity.

Increasing carbon dioxide (CO₂) exhalation may reduce build-up of lacticacid, as CO₂ in solution acts as a buffer for hydrogen ions in the body.Increasing O₂ uptake may also reduce the buildup of lactic acid. Thus,respiratory performance improvement including increasing exhalation ofCO₂ and increasing O₂ uptake may reduce fatigue by reducing lactic acidbuildup that may result in improved performance.

Cortisol is a glucocorticosteroid hormone that affects various tissuesand organs in the human body. Cortisol may aid the body in responding tostress by, for example, maintaining cardiovascular functions. However,prolonged or excessively high levels of cortisol may cause fatigue,reduce endurance, suppress the immune system, and have other deleteriousphysiological effects. For example, protein synthesis, which isnecessary for repairing and increasing muscles, is important forrecovery following engagement in physical activity. However, elevatedlevels of cortisol have been shown to inhibit protein synthesis. Bylimiting the ongoing rise in cortisol levels, performance may beimproved.

Accordingly, there is a need for improved apparatus as well as relatedmethods that reduce build-up of lactic acid and cortisol duringengagement in physical activity.

BRIEF SUMMARY OF THE INVENTION

These and other needs and disadvantages may be overcome by the apparatusdisclosed herein. Additional improvements and advantages may berecognized by those of ordinary skill in the art upon study of thepresent disclosure.

A dental appliance apparatus is disclosed herein. In various aspects,the dental appliance may include a body removably attachable to one ormore teeth selected from premolars and molars, and a flange extendingforth from lingual portions of the body to contact a tongue at one ormore locations proximate the premolars and the molars in order to causea contraction of the genioglossus that positions the tongue anteriorlyand downward toward the mandible by stimulation of the hypoglossalnerve. The dental appliance may include a connector connected to thebody, and the connector may pass about buccal-labial sides of theanterior teeth. A bumper may be included on a labial side of theconnector, and the bumper may contact the lips to promote pursed lipsbreathing. An anterior flange may extend lingually from the connector tostimulate the hypoglossal nerve proximate a tongue tip of the tongue inorder to cause contraction of the genioglossus that positions the tongueanteriorly and downward toward the mandible.

Related methods of use of the dental appliance may include the step ofreceiving a dental appliance within a mouth of a user, and may includethe step of causing contraction of the genioglossus that positions thetongue anteriorly and downward toward the mandible by stimulating thehypoglossal nerve through contact of the hypoglossal nerve with moreflanges that extend forth from lingual portions of the dental appliance.The hypoglossal nerve may be stimulated at various locations around thetongue including the side of the tongue and proximate the tip of thetongue, and flanges may be provided at various locations about thedental appliance to so stimulate the hypoglossal nerve by contact withthe tongue.

This summary is presented to provide a basic understanding of someaspects of the apparatus and methods disclosed herein as a prelude tothe detailed description that follows below. Accordingly, this summaryis not intended to identify key elements of the apparatus and methodsdisclosed herein or to delineate the scope thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates by top frontal perspective view an exemplaryimplementation of a dental appliance;

FIG. 1B illustrates by top rear perspective view the exemplaryimplementation of the dental appliance of FIG. 1A;

FIG. 1C illustrates by bottom perspective view the exemplaryimplementation of the dental appliance of FIG. 1A;

FIG. 2 illustrates by plan view the exemplary implementation of thedental appliance of FIG. 1A in engagement with the mandibular teeth;

FIG. 3A illustrates by cross-sectional view portions of the exemplaryimplementation of the dental appliance of FIG. 1A in engagement with amandibular tooth;

FIG. 3B illustrates by cross-sectional view portions of the exemplaryimplementation of the dental appliance of FIG. 1A in engagement withmandibular teeth;

FIG. 3C illustrates by cross-sectional view portions of the exemplaryimplementation of the dental appliance of FIG. 1A in engagement with ananterior mandibular tooth;

FIG. 4A illustrates by cross-sectional view another exemplaryimplementation of a dental appliance in engagement with an anteriormandibular tooth;

FIG. 4B illustrates by cross-sectional view yet another exemplaryimplementation of a dental appliance in engagement with an anteriormandibular tooth;

FIG. 5A illustrates by top view portions of the exemplary implementationof the dental appliance of FIG. 1A;

FIG. 5B illustrates by top view portions of an exemplary implementationof a dental appliance;

FIG. 5C illustrates by frontal view portions of the exemplaryimplementation of the dental appliance of FIG. 1A;

FIG. 5D illustrates by frontal view portions of the exemplaryimplementation of FIG. 5B;

FIG. 6A illustrates by top rear perspective view an exemplaryimplementation of a dental appliance;

FIG. 6B illustrates by bottom rear perspective view the exemplaryimplementation of the dental appliance of FIG. 6A;

FIG. 6C illustrates by cross-sectional view the exemplary implementationof the dental appliance of FIG. 6A;

FIG. 7A illustrates by plan view portions of an exemplary implementationof a dental apparatus in engagement with a mouth;

FIG. 7B illustrates by plan view portions of another exemplaryimplementation of a dental apparatus in engagement with a mouth;

FIG. 8 illustrates by bar graph experimental results from Experiment 1;and,

FIG. 9 illustrates by side cross-sectional view an exemplaryimplementation of a dental apparatus in engagement with the mouth, thedental appliance in communication with the tongue, features of theanatomy of the tongue being illustrated in cross-section at a locationalong the anterior-posterior direction, the cross-section beingperpendicular to the anterior-posterior direction.

The Figures are exemplary only, and the implementations illustratedtherein are selected to facilitate explanation. The number, position,relationship and dimensions of the elements shown in the Figures to formthe various implementations described herein, as well as dimensions anddimensional proportions to conform to specific force, weight, strength,flow and similar requirements are explained herein or are understandableto a person of ordinary skill in the art upon study of this disclosure.Where used in the various Figures, the same numerals designate the sameor similar elements. Furthermore, when the terms “top,” “bottom,”“right,” “left,” “forward,” “rear,” “first,” “second,” “inside,”“outside,” and similar terms are used, the terms should be understood inreference to the orientation of the implementations shown in thedrawings and are utilized to facilitate description thereof. Use hereinof relative terms such as generally, about, approximately, essentially,may be indicative of engineering, manufacturing, or scientifictolerances such as ±0.1%, ±1%, ±2.5%, ±5%, or other such tolerances, aswould be recognized by those of ordinary skill in the art upon study ofthis disclosure.

DETAILED DESCRIPTION OF THE INVENTION

The dental appliance disclosed herein, in various aspects, may beremovably attached to at least a portion of the teeth of the user. Thedental appliance disclosed herein, in various aspects, may enhancerespiratory performance of the user by interaction with variousanatomical features of the mouth, jaw, or face, and, thus, increaseathletic performance of the user. In various aspects, the dentalappliance may afford protection to the teeth, tongue, lips, mandible, orother anatomical features of the mouth, jaw, or face.

The design of the dental appliance, in various aspects, is such that,when the dental appliance is positioned in the mouth, with theindividual biting down, the dental appliance stimulates the hypoglossalnerve (XII cranial nerve) causing the genioglossus (tongue protrudingmuscle) to protrude/contract in a forward motion. This forwardcontraction of the genioglossus results in an increased oropharynxopening in the throat (Garner, D. P. and McDivitt, E., Effects ofmouthpiece use on airways openings and lactate levels in healthy collegemales. Compendium: A Supplement of Continuing Education in Dentistry,30(2): 9-13 (2009) and Garner, D. P., Effects of various mouthpieces onrespiratory physiology during steady state exercise in college-agedsubjects. Gen Dent, 63, 30-34 (2015)).

Thus, when a user starts exercising, he/she should breathe through themouth, while biting down on the mouthpiece. This may result in a type ofpursed lip breathing which has been shown to lower ventilation, whileimproving oxygen and carbon dioxide kinetics and lactate levels duringand after endurance exercise. While exercising anaerobically(specifically resistance exercise), the user should clench down andbreathe through his/her mouth. This has been shown to decrease cortisollevels post exercise (see study by Garner, Dudgeon, McDivitt andScheett, The effects of mouthpiece use on gas exchange parameters duringsteady-state exercise in college-aged men and women. J Am. Dent. Assoc.2011 142(9) 1041-1047 and Garner, D. P., Dudgeon, W. D., and McDivitt,E., The effects of mouthpiece use on cortisol levels during an intensebout of resistance exercise. Journal of Strength and Conditioning,25(10): 2866-2871(2011).

As used herein, ventilation is the measure of air into and out of thelunges, and respiratory rate is the measure of the exchange of oxygenand carbon dioxide within the lungs. Specifically, ventilation is thedefined as the liters per minute. Respiratory rate is defined herein asbreaths per minute. Tidal volume is defined herein as the volume of airinhaled and exhaled during one breath.

Anterior, as used herein, refers to portions of the mouth proximate thefront of the mouth for example, proximate the lips or the frontincisors. Posterior, as used herein, refers to the back of the mouth,for example, proximate the 3rd molar (if present) or the pharynx.Mesial, as used here, refers to the midline of the mouth. The centralincisors are usually located on either side of the mesial line ormidline. For example, a structure that extends mesially may extendtoward the mesial line or midline, and a structure that is positionedmesially may be positioned about the mesial line or midline. Axial, asused herein, refers to directions along a vertical axis of the body as,for example, generally defined by the spinal column.

The tongue is a complex collection of muscles and nerves that may bestimulated in various ways either directly or indirectly by the dentalappliance. The tongue muscles may be divided functionally into protrudermuscles that move the tongue blade in the anterior direction andretractor muscles that pull the tongue in the posterior direction towardthe posterior pharyngeal wall. Protruder muscles include the extrinsicgenioglossus, the intrinsic verticalis and transversus muscles.Retractor muscles include the extrinsic hyoglossus and styloglossus, andthe intrinsic inferior and superior longitudinalis muscles. Stimulationof both the genioglossus and hyoglossus may cause depression of thetongue.

The tongue muscles are innervated by branches of the hypoglossal nerve,which is the twelfth cranial nerve. The hypoglossal nerve trunkbifurcates into large mesial and lateral branches as the hypoglossalnerve approaches the tongue muscles, with the mesial branch containingaxons supplying the protruder muscles (both intrinsic and extrinsicmuscles) and the lateral branch the retractors.

The hypoglossal motor nucleus receives both excitatory and inhibitorysynaptic input from many brain regions. Direct inputs originate in thenucleus of the solitary tract, the majority of the reticular nuclei, theprincipal and spinal trigeminal nuclei, reticularis subcoeruleus, thecaudal Raphe nucleus, and the Kolliker-Fuse nucleus. These regions, inturn, receive substantia nigra, the superior colliculus, and themesencephalic trigeminal nucleus. Many of these regions modulateventilatory drive, with the reticular formation containing theinterneurons that link the central respiratory drive from thepre-Bötzinger complex with the hypoglossal motor nucleus. Accordingly,the tongue including the tongue muscles may be connected to respiratoryperformance through the hypoglossal nerve, so that respiratoryperformance may be increased by stimulating the tongue or positioningthe tongue in certain positions. Increased respiratory performance mayreduce fatigue by reducing lactic acid formation, and increasedrespiratory performance may reduce cortisol levels, which may promotemuscle healing and have other beneficial effect.

For example, pursing of the lips appears to correlate with contractionof the genioglossus including expansions or contractions of other tonguemuscles thereby positioning the tongue anteriorly and downward towardthe mandible. When engaging in pursed lips breathing, the subject pursestheir lips while breathing in and breathing out slowly. There are twotypes of pursed lips breathing with one being a decrease in respiratoryrate and an increase in tidal volume and the other type of pursed lipsbreathing being one with a decrease in respiratory rate with no changein tidal volume. It has been found that subjects with chronicobstructive pulmonary disease (COPD) experienced a subsequent andsignificant reduction in respiratory rate with faster recovery whensubjects with COPD practiced pursed lip breathing while exercising, sothat pursed lips breathing may be associated with increased respiratoryperformance.

As noted above, pursed lip breathing may be correlated with thecontraction of the genioglossus. Studies of the genioglossus have foundthat contraction of the genioglossus may cause dilation of thepharyngeal airway. Particularly, when the genioglossus is contracted(i.e. the tongue is pushed down toward the mandible and forward towardthe anterior teeth), there is a subsequent relaxation of the pharyngealarea in the back of the throat. Thus, pursed lips breathing may causecontraction of the genioglossus muscle that, in turn, causes dilation ofthe pharyngeal airway, resulting in the observed increased respiratoryperformance with pursed lips breathing. Thus, a dental appliance thatpromotes pursed lips breathing may increase respiratory performance.

In addition, stimulation of the hypoglossal nerve at various locationsby the dental appliance may cause contraction of the genioglossus thatpositions the tongue down and anteriorly thereby resulting in dilationof the pharyngeal airway and concomitant increased respiratoryperformance. Various stimulations of the hypoglossal nerve by the dentalappliance may otherwise signal various other nerves, nuclei, or regionsof the brain that may produce various physiological effects thatincrease respiratory performance. Genioglossus may include thegenioglossus as well as other protruder and retractor muscles, andcontraction of the genioglossus may include movement of the otherprotruder muscles or movement of the retractor muscles, as would bereadily understood by those of ordinary skill in the art upon study ofthis disclosure.

A forward shift of the mandible such as may occur with the dentalappliance implementations disclosed herein may increase the pharyngealarea. Applicant has found airway anatomical differences with variousimplementations of the dental appliance, specifically measuring thediameter and width of the oropharynx with computed tomography (CT) scansthat demonstrated a 9% improvement in both the diameter and width whensubjects used the dental appliance. (See Garner, D. P. and McDivitt, E.,Effects of mouthpiece use on airways openings and lactate levels inhealthy college males. Compendium: A Supplement of Continuing Educationin Dentistry, 30(2): 9-13 (2009)). Although the mandibular displacementof that implementation of the dental appliance was not as pronounced asthose with a sleep apneic device, a significant effect on oropharynxwidth occurred when using the dental appliance.

Finally, it was found that implementations of the dental appliance thatallowed subjects to clench all their teeth evenly with verticaldisplacement and a level pressure distribution between all teethresulted in increased respiratory performance.

In various aspects, the dental appliance may comprise two bodiesreceived on either side of the mouth with the two bodies connected toone another by a connector. The bodies may be constructed of a pluralityof material layers bonded or otherwise secured to one another in variousways. In general, the body portions of the dental appliance may becomposed of one or more layers of materials. These materials may includeethyl-vinyl acetate (EVA); thermoplastic polyolefin, variousethylene-based elastomers; various hydrocarbon resins (which are may becombined with EVA, thermoplastic polyolefin, or various ethylene-basedelastomers), polycaprolactone (which may be combined with EVA),low-density polyethylene, high density poly-ethylene, polycarbonateand/or various polymers, laminates and other materials that will berecognized by those skilled in the art upon review of the presentdisclosure. In certain aspects, the composite material may be apre-laminated sheet including a layer of polycarbonate bound to a layerof polyester urethane which is available under the trade name Durasoft®from the Scheu Dental Co. located in Iserlohn, Germany. Typically, thesematerials may be selected with a durometer (hardness) of between about70 A to about 96 A or between about 55D and about 90D.

As described herein, in various aspects, one of the material layers ofthe plurality of material layers is a bite pad, and another of thematerial layers is an occlusal pad. Various other material layer(s) maybe interposed between the bite pad and the occlusal pad, and additionalmaterial layer(s) may be placed about the occlusal pad or about the bitepad, in various aspects. The dental appliance may be constructed, atleast in part, of the bite pad bonded to the occlusal pad, and the bitepad with the occlusal pad bonded thereto forms at least a portion of thedental appliance. In various aspects, the bite pad may support theocclusal pad, may interact with other elements of the dental appliance,and may confer various mechanical properties upon the dental appliance.The bite pad may interact with the teeth, and, thus, may be configuredwith treads including other tooth grippable surface, and the bite padmay have a selected hardness as indicated, for example, by a Shorehardness value as measured by a durometer. In various aspects, theocclusal pad may engage the user's teeth to attach removably the dentalappliance thereto, and the occlusal pad may be custom fitted to engagethe user's teeth. The occlusal pad may have a selected hardness asindicated, for example, by a Shore hardness value.

The bite pad is composed of one or more bite pad materials. In variousaspects, the bite pad material may include a mixture of styrene blockcopolymer and ethylene vinyl acetate (EVA). An exemplary styrene blockcopolymer is available as DYNAFLEX® part number G2782 from GLSCorporation, Thermoplastic Elastomers Division, 833 Ridgeview Dr.,McHenry, Ill. 60050. EVA is available from a number of sources, such asthe ELVAX® resins from Dupont Packaging and Industrial Polymers, 1007Market Street, Wilmington, Del. 19898.

In various aspects, the bite pad material may include a mixture of astyrene block copolymer and a polyolefin elastomer. The polyolefinelastomer may be a copolymer of ethylene and octene-1. An exemplarycopolymer is available as ENGAGE® from Dupont Canada, Inc., P.O. Box2200, Streetsville, Mississauga, Ontario L5M 2H3.

The bite pad material may include, in various aspects, a mixture of athermoplastic rubber, which includes thermoplastic elastomer andthermoplastic urethane, with a polyolefin elastomer. Exemplarythermoplastic rubbers are Santoprene® thermoplastic elastomer fromAdvanced Elastomer Systems, L. P., 388 South Main Street, Akron, Ohio44311 and Kraton® thermoplastic elastomer from the Shell Oil Company,Houston, Tex. Kraton® includes a styrene-ethylenelbutylenes-styreneblock copolymer. In various aspects, the bite pad material may includepolypropylene part number AP6112-HS from Huntsman Corporation,Chesapeake, Va. 23320. In various aspects, the bite pad material mayinclude HD-6706 ESCORENE® Injection Molding Resin [a high-densitypolyethylene] from ExxonMobil Chemical Company, P.O. Box 3272, Houston,Tex.

The bite pad material of the bite pad, in various aspects, may have adurometer of at least 60D to resist substantial deformation andretaining a substantially planar configuration between at least twocusps of the teeth of the user when the teeth of the user are clenchedabout the bite pad. In various aspects, the bite pad material of thebite pad may have a durometer of between about 60D to about 90D althoughthis may vary. In some aspects, the bite pad material of the bite padhas a Shore A hardness of about 82.

The occlusal pad is composed of one or more occlusal pad materials. Invarious aspects, the occlusal pad material may be transformable betweena pliable state and a non-pliable state. In the pliable state, theocclusal pad material of the occlusal pad may be shaped to conform tothe teeth of the user. In the non-pliable state, the occlusal padmaterial of the occlusal pad generally retains its conformance to theteeth of the user as shaped when in the pliable state. In variousaspects, the occlusal pad may be transformed between the pliable stateand the non-pliable state by heating and cooling, respectively. Forexample, heating the occlusal pad material in warm water may allow theocclusal pad to be fitted to the user's teeth and, after having beenfitted, the occlusal pad material may be cooled to the non-pliant statethereby capturing the fit of the user's teeth in the occlusal padmaterial. The occlusal pad material is transformed from the non-pliablestate to the pliable state at a temperature tolerable by the user uponplacement of the occlusal pad material in the pliable state within theuser's mouth, in various aspects. The occlusal pad material maytransform between the non-pliant and pliant state at a temperaturegreater than human body temperature but less than about 100° C., invarious implementations.

In various aspects, the occlusal pad material of the occlusal padincludes a mixture of polycaprolactone. An exemplary polycaprolactone isCapra 6500 polycaprolactone from Perstorp, UK Limited, Warrington,Cheshire UK. In various aspects, the occlusal pad material of occlusalpad 40 includes a mixture of polycaprolactone and ethylene vinyl acetate(EVA) such as ELVAX®. In various aspects, the occlusal pad material ofocclusal pad 40 includes ethylene vinyl acetate (EVA) alone, such asELVAX®. In various aspects, the occlusal pad material of occlusal pad 40includes a mixture of polycaprolactone and a polyolefin elastomer, andthe polyolefin elastomer may be a copolymer of ethylene and octene-1. Anexemplary copolymer is available as ENGAGE® from Dupont Canada, Inc.,P.O. Box 2200, Streetsville, Mississauga, Ontario L5M 2H3.

FIGS. 1A, 1B and 1C illustrate an exemplary implementation of a dentalappliance 10. As illustrated in FIGS. 1A, 1B and 1C, exemplary dentalappliance 10 includes bodies 20, 22 connected to one another byconnector 70. The dental appliance 10, as illustrated in FIGS. 1A, 1Band 1C, is formed as a generally U-shaped member, the curved portions ofthe “U” extends around anterior portions of the user's mouth as anteriorportion 16 of dental appliance 10, and the straight portions of the “U”extend from the anterior toward the posterior of the mouth withposterior ends 15, 17 of dental appliance 10. When dental appliance 10is positioned in the mouth, dental appliance 10 defines a buccal-labialside 12 that is generally oriented toward the cheeks and/or lips of theuser and a lingual side 14 that is generally oriented toward the user'stongue. Anterior portion 16 of dental appliance 10 is positionedanteriorly mesially, as illustrated in the Figures, and posterior ends15, 17 are positioned posteriorly in the mouth.

Connector 70 includes bumper 80, and occlusal pads 40, 42 includeflanges 90, 92, in this implementation. Bodies 20, 22 of exemplarydental appliance 10 include occlusal pads 40, 42 bonded to bite pads 30,32, respectively. As illustrated, side 46 of occlusal pad 40 is bondedto side 36 of bite pad 30 and side 48 of occlusal pad 42 is bonded toside 38 of bite pad 32. Sides 36, 38, are generally oriented opposite tosides 37, 39 of bite pads 30, 32, respectively, and sides 46, 48, aregenerally oriented opposite to sides 47, 49 of occlusal pads 40, 42, inthis implementation.

Occlusal pads 40, 42 define occlusal pad channels 56, 58 in sides 47,49, respectively, in this implementation. In exemplary dental appliance10, occlusal pad channels 56, 58 may removably engage teeth on opposingsides of the mandible generally in the posterior portion of themandible. For example, occlusal pad channels 56, 58 of dental appliance10 engage the mandibular 1^(st) bicuspid, mandibular 2^(nd) bicuspid,mandibular 1^(st) molar, mandibular 2^(nd) molar, and mandibular 3^(rd)molar on the right and left sides, respectively. Occlusal pad channels56, 58 may be fit to the user's teeth in order to conform to the shapeof the user's teeth including interstices between the user's teeth. Notethat the mandibular 3^(rd) molars (left and right; i.e. wisdom teeth)may be omitted from the illustrations and discussion herein for clarityof explanation and because the mandibular 3^(rd) molars are frequentlyabsent.

The occlusal pad channels 56, 58 are elongated, as illustrated, and aregenerally oriented along the mesial-distal axis. The at least a portionof occlusal pad channels 56, 58 may extend over one or more of thecanines, premolars and/or molars on each side of the mouth. The occlusalpad channels 56, 58 may be configured in shape of the teeth of the user.A channel occlusal surface 57, 59 of occlusal channels 56, 58,respectively, contacts at least a portion of the occlusal surface of theteeth. The channel occlusal surfaces 57, 59 may be configured to conformto a least a portion of the occlusal surface of the user's teeth and maybe configured to conform to the surfaces of all of the teeth received inthe occlusal channels 56, 58. To conform, typically, cavities will beformed in the channel occlusal surfaces 57, 59 that correspond to atleast the cusps of the occlusal surfaces of the teeth. In certainaspects, this may more evenly distribute the force from clenching or animpact over the occlusal surface of the teeth and, among other things,may also improve retention and fitment of dental appliance 10.

When occlusal pad channels 56, 58 of occlusal pads 40, 42 are engagedwith the teeth of the mandible, sides 47, 49 of occlusal pads 40, 42 areoriented toward the gum of the mandible and sides 37, 39 of bite pads30, 32 are oriented toward teeth of the upper jaw. The teeth of theupper jaw may engage with sides 37, 39 of bite pads 30, 32,respectively. Sides 37, 39 of bite pads 30, 32 may include treads and soforth, and may otherwise be generally adapted to contact occlusalsurfaces of posterior teeth of the upper jaw opposite to the mandibularteeth engaged with occlusal pad channels 56, 58 of occlusal pads 40, 42.

Bite pads 30, 32 may be of sufficient hardness to resist substantialpenetration by the teeth and deformation as the teeth of the user areclenched about bite pads 30, 32. Bite pads 30, 32 may be formed from amaterial such as, for example, high density polyethylene orpolypropylene that may have a durometer of between about 60D to about90D.

As illustrated in FIGS. 1A, 1B, and 1C, body 20 and body 22 areconnected to one another by connector 70, so that connector 70 securesbody 20 and body 22 to one another. Connector 70 may be formed of avariety of materials including those materials set forth herein as beingsuitable for use in occlusal pads or of other materials or combinationsof materials, as would be recognized by those of ordinary skill in theart upon study of this disclosure.

Connector 70 may be configured to extend as an arch around either thelingual side, labial side, or both the lingual side and labial side ofthe anterior teeth of the user, in various implementations. In certainimplementations, connector 70 may extend along or just below the gumline on dental appliance 10, which is configured to be removablyattached to the mandibular teeth.

Connector 70 and occlusal pads 40, 42 may be formed as a unitarystructure in some implementations such that connector 70 extends betweenocclusal pads 40, 42, as illustrated. In other implementations,connector 70 and bite pads 30, 32 may be formed as a unitary structure,such that connector 70 extends between bite pads 30, 32. In still otherimplementations, connector 70 may be attached to bite pads 30, 32,occlusal pads 40, 42, or both bite pads 30, 32 and occlusal pads 40, 42by, for example, various adhesives, mechanical connections, thermalbonding, and combinations thereof.

When dental appliance 10 is positioned in the mouth with occlusal padchannels 56, 58 engaged with posterior mandibular teeth, connector 70generally passes about labial potions of the anterior mandibular teethof the user with side 71 of connector 70 biased against the anteriormandibular teeth, and side 73 of connector 70 is oriented labially (i.e.toward the lips). Note that side 71 of connector 70 is fit to the user'steeth, in this implementation, so that side 71 conforms to the shape ofthe user's teeth including the interstices between the teeth.

As illustrated in FIGS. 1A, 1B and 1C, bumper 80 extends forth from side73 of connector 70 generally mesially along connector 70. Bumper 80 maybe formed of the same material as connector 70 so that connector 70 andbumper 80 form a unitary structure, in some implementations. In otherimplementations, bumper 80 may be secured to connector 70 by, forexample, adhesive, mechanical connector(s), or thermal bond(s), andbumper 80 may be formed of various materials, as would be recognized bythose of ordinary skill in the art upon study of this disclosure. In yetother implementations, bumper 80 may be removably attachable toconnector 70 to allow the user to either attach bumper 80 to connector70 or remove bumper 80 from connector 70 as the user may desire.

Flanges 90, 92 extend forth mesially from lingual side 14 of dentalappliance generally along the straight portions of the “U,” asillustrated in FIGS. 1A, 1B and 1C. Flange 90 extends mesially from body20 with edge 91 of flange 90 being of a scalloped configuration, asillustrated. Similarly, as illustrated, flange 92 extends mesially frombody 22 with edge 93 of flange 92 being of a scalloped configuration.When dental appliance 10 is engaged with the mandibular teeth, sides 98,99 of flanges 90, 92 are oriented generally toward the palate, whilesides 96, 97 of flanges 90, 92 are oriented generally toward themandible. Flanges 90, 92 are oriented so that sides 98, 99 are set apartfrom the palate, in this implementation, resulting is no contact betweenflanges 90, 92 including sides 98, 99, respectively, and the palate whendental appliance 10 is engaged with the mandibular teeth.

As illustrated, flanges 90, 92 are somewhat wedge-shapes with the broadpart of the wedge being where flanges 90, 92 emerge from lingual side 14of dental appliance 10 and flanges 90, 92 then tapering to form edge 91,93. In other implementations, flanges 90, 92 may be more planar in shapewith generally constant thickness between sides 96, 98 and generallyconstant thickness between sides 97, 99. Flanges 90, 92 extend mesiallya distance sufficient to impinge upon the side of the tongue therebycompressing portions of the genioglossus while avoiding creating a gagresponse, the distance being specific to the anatomy of the user, invarious implementations.

Edges 91 93 are formed along the side of flanges 90, 92 that extendfurthest in the mesial lingual direction. Edges 91, 93 are sufficientlyblunt (illustrated as being rounded but other implementations may haveother shapes) so that edges 91, 93 do not injure the tongue. The axialdimension of edge 91, 93 is less than the axial dimension of bases 20,22 as given, for example, by the length between side 39 and side 49 orthe length between lingual body edge 133 and side 39.

Flanges 90, 92 are exemplary, and flange as used herein may includeprotuberances, extensions, or structures that extend forth from thelingual side of the dental appliance and are configured to touch thetongue in order to stimulate the hypoglossal nerve of the tongue, forexample, by compression of the genioglossus including other muscles ortissues of the tongue. The flanges 90, 92 may stimulate the hypoglossalnerve by touching portions of the tongue enervated by thy hypoglossalnerve such as portions of the tongue along the side of the tongue.Flanges, such as flanges 90, 92, may have other shapes in otherimplementations. Edges 91, 93 are exemplary, and edge as used herein mayinclude portions of the flange that generally contact the tongue tostimulate the hypoglossal nerve.

The implementation of dental appliance 10 includes supports 52(illustrated in phantom) that are imbedded within flanges 90, 92 tosupport structurally flanges 90, 92. Flanges 90, 92 may be of unitaryconstruction with the occlusal pads 40, 42, so that flanges 90, 92 areformed of the same material as occlusal pads 40, 42 and molded aroundsupports 52. Supports 52, in this implementation are cantilevered frombite pads 30, 32 with support ends 51 of supports 52 secured to bitepads 30, 32. Supports 52 may be of unitary construction with bite pads30, 32, or support ends 51 of supports 52 may be attached to bite pads30, 32, for example, by adhesive. Supports 52 have a “T” shape atsupport ends 53, but may have, for example, a “Y” shape, or other shapeor combination of shapes, in other implementations. Various numbers ofsupports 52 may be included in various implementations of dentalappliance 10, or, in some implementations, supports 52 may be omittedentirely. In other implementations, flanges, such as flanges 90, 92, mayextend lingually mesially from bite pads, such as bite pads 30, 32, andmay be formed of the same material as the bite pads, or flanges mayextend forth from other portions of a lingual side of a dentalappliance, such as lingual side 14 of dental appliance 10.

FIG. 2 illustrates dental appliance 10 received in the mouth and engagedwith the mandibular teeth 105 of the user. As illustrated in FIG. 2,tooth 500 a, 500 b, 500 c, 500 d, 500 e, 500 f, 500 g are the leftmandibular 2^(nd) molar, left mandibular 1^(st) molar, left mandibular2^(nd) bicuspid, left mandibular 1^(st) bicuspid, left mandibularcuspid, left mandibular lateral incisor, left mandibular centralincisor, respectively. Tooth 500 h, 500 i, 500 j, 500 k, 500 l, 500 m,500 n, are the right mandibular central incisor, right mandibularlateral incisor, right mandibular cuspid, right mandibular 1^(st)bicuspid, right mandibular 2^(nd) bicuspid, right mandibular 1^(st)molar, right mandibular 2^(nd) molar, respectively, as illustrated inFIG. 2.

As illustrated in FIG. 2, edge 91 of flange 90 is biased against atleast portions of side 110 of the portion of the tongue 100 generallyadjacent teeth 500 k, 500 l, 500 m, 500 n on the right side of themandible when body 20 of dental appliance 10 is engaged with themandibular teeth. Edge 93 of flange 92, as illustrated in FIG. 2, isbiased against portions of side 112 of the portion of the tongue 100generally adjacent teeth 500 a, 500 b, 500 c, 500 d on the left side ofthe mandible when body 22 of dental appliance 10 is engaged with themandibular teeth.

The biasing of edges 91, 93 of flanges 90, 92 against at least portionsof sides 110, 112, respectively, of tongue 100 may compresses thegenioglossus along the side of the tongue or may otherwise physicallytouch the tongue to stimulate the hypoglossal nerve. Stimulation of thehypoglossal nerve by flanges 90, 92 may cause contraction of thegenioglossus that positions the tongue 100 anteriorly and lowered towardthe mandible, which may result in dilation of the pharyngeal airway and,thus, increased respiratory performance. Scalloped edges 91, 93, asillustrated, may be more effective in stimulating the hypoglossal nervethan straight edges, as, for example, the scalloped edges maydifferentially compress the genioglossus or otherwise differentiallystimulate the tongue. For example, peaks of the scallop shape maycompress the genioglossus while the valleys of the scallop shape maycompress the genioglossus a lesser amount than the peaks or may avoidcompressing the genioglossus altogether. Edges, such as edges 91, 93,may have waved, straight, saw-tooth, or other configurations orcombinations of configurations, in other implementations.

Occlusal pad channels 56, 58 of bodies 20, 22 engage teeth 500 k, 500 l,500 m, 500 n on the right side and teeth 500 a, 500 b, 500 c, 500 d onthe left side, respectively, as illustrated in FIG. 2. Posterior ends15, 17 of bodies 20, 22 are generally positioned posteriorly coincidentwith teeth 500 n, 500 a on the right and left side, respectively, asillustrated, and anterior portion 16 is positioned anteriorly aboutmesial line 114. Anterior ends 26, 28 of bodies 20, 22 are positioned ator posterior to tooth 500 k, 500 d, respectively, when dental appliance10 is received in the mouth of a user, as illustrated.

Note that the mandibular 3^(rd) molars (left and right; (i.e. wisdomteeth) are omitted from FIG. 2 both for clarity of explanation andbecause the mandibular 3^(rd) molars are frequently absent. It should beunderstood that occlusal pad channels 56, 58 of dental appliance 10 mayengage the mandibular 3^(rd) molars when the mandibular 3^(rd) molar(s)are present. Flanges 90, 92 may generally extend in theanterior-posterior direction from the mandibular 1^(st) bicuspid to themandibular 3^(rd) molar when, for example, the mandibular 3^(rd) molarsare present) or flanges 90, 92 may generally extend in theanterior-posterior direction from the mandibular 1^(st) bicuspid to themandibular 2^(rd) molar, for example, when the mandibular 3^(rd) molaris absent. In various implementations, flanges 90, 92 may extend in theanterior-posterior direction adjacent at least portions of one or moreteeth selected from the mandibular 2^(nd) molar 500 a, 500 n, mandibular1^(st) molar 500 b, 500 m, mandibular 2^(nd) bicuspid 500 c, 500 l,mandibular 1^(st) bicuspid 500 d, 500 k. In various implementations,edges 91, 93 may extend in the anterior-posterior direction adjacent atleast portions of one or more teeth selected from the mandibular 2^(nd)molar 500 a, 500 n, mandibular 1^(st) molar 500 b, 500 m, mandibular2^(nd) bicuspid 500 c, 500 l, mandibular 1^(st) bicuspid 500 d, 500 k.

Connector 70 generally passes about buccal-labial potions of theanterior mandibular teeth of the user with side 71 of connector 70biased against the anterior mandibular teeth, for example teeth 500 e,500 f, 500 g, 500 h, 500 i, 500 j, and side 73 of connector 70 isoriented labially (i.e. toward the lips), as illustrated in FIG. 2. Side71 of connector 70, as illustrated in FIG. 2, is biased against themandibular cuspid, the mandibular lateral incisor, and the mandibularcentral incisor on both the left and right sides.

As illustrated in FIG. 2, side 83 of bumper 80 is biased againstinterior side 121 of lower lip 120 proximate mesial line 114. Bumper 80does not intrude between the lips but merely biases against the interiorside 121 of lower lip 120 so that bumper 80 remains entirely within themouth cavity. The biasing of bumper 80 against the lower lip 120 (andthe upper lip in some implementations) stimulates the lower lip 120 (orboth lips) causing the lips to purse. Bumper 80 may assume variousshapes that promote the pursing of the lips. Pursing of the lips inresponse to stimulation by bumper 80 may cause contraction of thegenioglossus thereby positioning the tongue 100 anteriorly and loweredtoward the mandible, which may result in dilation of the pharyngealairway and, thus, increased respiratory performance.

Portions of connector 70 extend posteriorly from lingual side 66 oftooth 62 to form anterior flange 74 with posterior end 75. Anteriorflange 74 may extend a distance T from the centerline of tooth 62 toposterior end 75, as illustrated in FIG. 3C, with tooth 62 selected, forexample, from tooth 500 e, 500 f, 500 g, 500 h, 500 i, 500 j. Posteriorend 75 is positioned to engage portions of the tongue 100 proximatetongue tip 113 in order to stimulate tongue 100, as illustrated in FIGS.2 and 3C. Tongue tip 113 in the illustration is located generally alonglabial portions of tongue 100, for example, along teeth 500 e, 500 f,500 g, 500 h, 500 i, 500 j. Anterior flange 74 may be mesiallysymmetric, and anterior flange 74 may extend along connector 70, forexample, from the tooth 500 e to tooth 500 j, from tooth 500 f to tooth500 i, or from tooth 500 g to tooth 500 h, in various implementations.

Engagement of anterior flange 74 including posterior end 75 or side 78with portions of the tongue 100 proximate tongue tip 113 as well as theposition of anterior flange 74 with respect to connector 70 may causecontraction of the genioglossus, and may, by the location of side 78,position the tongue 100 anteriorly and lowered toward the mandible,which may result in dilation of the pharyngeal airway and, thus,increased respiratory performance.

It should be noted that stimulation of the lip(s), such as lip 120, bybumper 80 and contraction of the genioglossus caused by stimulation oftongue 100 at various locations by flanges 74, 90, 92 all potentiallyimplicate stimulation of the hypoglossal nerve including the trigeminalnerve (fifth cranial nerve), and various portions of the brain incommunication with the hypoglossal nerve or the trigeminal nerve thatmay be associated with respiration. Thus, such stimulation of the tongueat various locations by flanges 74, 90, 92 as well as pursed lipsbreathing as provoked by bumper 80 may increase respiratory performanceis other ways that may or may not be known at present.

FIG. 3A illustrates body 22 of dental appliance 10 engaged withmandibular tooth 106, where mandibular tooth 106 may be selected, forexample, from tooth 500 a, 500 b, 500 c, 500 d. As illustrated in FIG.3A, body 22 includes bite pad 32, occlusal pad 42, and flange 92. Bitepad 32 is secured to occlusal pad 42, and mandibular teeth, such asteeth 500 a, 500 b, 500 c, 500 d, are received in occlusal channel 58 ofocclusal pad 42, as illustrated. While FIGS. 3A and 3B and the attendantdiscussion are directed toward body 22 of dental appliance 10 forexplanatory purposes, it should be recognized that body 20 of dentalappliance 10 may be configured similarly to body 22 of dental appliance10. Also, while body 20, 22 of exemplary dental appliance 10 includesbite pads, 30, 32 bonded to occlusal pads 40, 42, respectively, itshould be recognized that bite pads 30, 32 or occlusal pads 40, 42 maybe comprised of multiple layers of materials. It should be furtherrecognized that body 20, 22 may include additional layer(s) ofmaterial(s) or combinations of materials that may impart variousmechanical functionalities to bodies 20, 22. It should also berecognized that bite pads 30, 32 and occlusal pads 40, 42 may be of thesame material to form a unitary structure, in certain implementations.

When the teeth are engaged in the occlusal channel 58 of dentalappliance 10, a buccal body edge 131 of body 22 is positioned above thegum line of the user, as illustrated. In other implementations, buccalbody edge 131 may extend below the gum-line of the user, or portions ofbuccal body edge 131 may be above the gum-line while other portions ofbuccal body edge 131 may extend below the gum-line. In someimplementations, the buccal body edge 131 may be generally proximate theocclusal surface of the teeth so that the buccal side of occlusalchannel 58 is either de minimis or omitted entirely.

Similarly, lingual body edge 133 may be variously positioned above thegum-line, as illustrated. Lingual body edge 133 may extend below thegum-line or portions of lingual body edge 133 may be above the gum-linewhile other portions of lingual body edge 133 may extend below thegum-line, in various implementations. In some implementations, thelingual body edge 133 may be generally proximate the occlusal surface ofthe teeth so that the lingual side of channel 58 is either de minimis oromitted entirely.

Flange 92, as illustrated, is of generally unitary construction withocclusal pad 42, and support 52 is cantilevered from bite pad 32 tosupport flange 92. Support end 51 of support 52 is attached to bite pad32, and support end 53 of support 52 has a “T” configuration, asillustrated, and support 52 lies internally within flange 92. Edge 93 offlange 92 may be biased against the side 112 of the portion of thetongue 100, for example, from about tooth 500 a to tooth 500 d. In otherimplementations, flange 92 may be of generally unitary construction withocclusal pad 42, or flange 92 may be of unitary construction with one ormore other layers interposed between bite pad 32 and occlusal pad 42.

As illustrated in FIG. 3B, body 22 is engaged with tooth 500 a, 500 b,500 c, 500 d. From a top view (see FIGS. 1A, 1B), bite pads 30, 32 mayhave an oblong shape, a generally rectangular shape, a kidney shape, anoval shape, an egg shape or be otherwise shaped to extend along at leasta portion of an occlusal surfaces of the teeth engaged with occlusal padchannels 56, 58 and the opposing maxillary teeth. The bite pads 30, 32are generally configured to space the occlusal surfaces of opposingteeth when a clenching force is exerted on bodies 20, 22 including bitepads 30, 32 by the user.

As illustrated in FIG. 3A, the width W of bite pad 32 may be selected tocontact or otherwise provide support between opposing teeth. The width Wmay be either constant or variable along the length L of bite pad 32, invarious implementations. The width W of bite pad 32 may be at least aswide as the distance between the cusps of individual adjacent teeth andthe cusps of the opposing maxillary teeth. In certain aspects, the widthW may be as wide or wider than the width of the adjacent teeth or atleast as wide as the spacing of the cusps of the teeth. Width W mayrange, for example, between about 5 mm and about 15 mm.

As illustrated in FIG. 3B, the length L of the bite pad 32 is selectedso that bite pad 32 extends along the teeth engaged with body 22. LengthL may range from about 10 millimeters to about 25 millimeters, invarious implementations.

The thickness t from the occlusal surface of a tooth, such as tooth 106,to side 39 of bite pad 32, as illustrated in FIGS. 3A, 3B, generallyestablishes the distance the mandibular teeth will remain separated fromcorresponding maxillary teeth when the jaw is clenched or when the jawreceives an impact while dental appliance 10 is attached. The thicknesst may be generally equivalent to the thickness of bite pad 32, invarious implementations.

As illustrated in FIG. 3B, thickness t generally decreases by Δt fromposterior end 17 to anterior end 19 to define a slope Δt/L. In variousimplementations, the slope, Δt/L may range from 1/100≤Δt/L≤ 1/20. Insome implementations, the slope may be about Δt/L=0 meaning no slope orgenerally constant thickness t along length L.

The thickness t may vary from about 1 mm to about 2 mm, in someimplementations. In various implementations, thickness t may begenerally about 5 mm at posterior end 17 and about 4 mm at anterior end19. Thickness t may be generally in the range of about 2 mm to about 6mm at proximal end 17 and thickness t may be generally in the range ofabout 1 mm to about 4 mm at anterior end 19. Most specifically, thethickness t may range approximately from 1.7 mm to 2.2 mm, while thethickness t at the anterior end 19 to side 39 of bite pad 32 at theanterior end 19 may range between approximately 0.7 mm to 1.2 mm. Insome implementations, the thickness t may approach 0.00 millimeters(e.g. an edge) at the anterior end 19. In various implementations, thebite pads slope, for example with 1 mm anterior end 19 increasinggradually in slope to 2 mm posterior end 17. Note that, inimplementations without a bite pad, such as bite pad 32, length L, widthW, thickness t, and slope Δt/L may be defined in reference to suchimplementations in ways as would be readily recognized by those ofordinary skill in the art upon study of this disclosure.

The slope Δt/L may enhance forward protrusion of the mandible (jaw) dueto the biting down on these bite pads, the lack of material on thebackside of the front bottom teeth, and the material on the inside ofthe dental appliance which aids in pushing the tongue in and forward, insuch implementations.

The bite pads 30, 32 elevate and create a minimal opening so that theindividual may clench on the dental appliance and breathe through themouth. If the thickness t too large, dental appliance 10 may notproperly stimulate the hypoglossal nerve in ways that result in apushing down and forward motion of the tongue, so that the dentalappliance 10 fails to function properly. If the thickness t too large, apressing down of the tongue by dental appliance 10 may not occur. Invarious other implementations, the thickness t may be between about 0.25millimeter and about 2.5 millimeters. Bite pads 30, 32 may have aconstant thickness with respect to length, a varying thickness withrespect to length, or either a constant or varying thickness along thewidth.

The effects of dental appliance 10 use on respiratory performance may berelated, at least in part, to the even contact between occlusal surfacesand bite pads 30, 32, which may be promoted by the slope Δt/L. The slopeΔt/L may allow all teeth to contact bite pads 30, 32 equally at maximalintercuspal positions. Laboratory results seem to indicate thatdifferences in the evenness of contact between teeth, along with varyingvertical dimensions have resulted in different outcomes (Garner, 2015).(See: Murakami, S., Maeda, Y., Ghanem, A., Uchiyama, Y., & Kreilborg, S.Influence of mouthguard on temporomandibular joint. Scand J Med Sports,18, 591-595 (2008); Pae, A., Yoo, R., Noh, K, Pake, J., & Kwon, K Theeffects of mouthguards on the athletic ability of professional golfers.Dent Traumatol, 29, 47-51 (2013))

For example, the slope of bite pad 32, as illustrated in FIG. 3B, alongwith a similar slope of bite pad 30 may cause a forward displacement ofthe mandible that may improve respiratory performance by increasing thepharyngeal area. In particular, the slope of bite pads 30, 32 may allowall the teeth in contact with bodies 20, 22 to be clenched more or lessevenly with minimal vertical displacement between the mandibular teethand the maxillary teeth. This may release the temporal mandibular jointallowing more forward displacement of the mandible resulting inincreased respiratory performance.

FIG. 3C illustrates a portion of connector 70 in engagement with tooth62 selected from tooth 500 f, 500 g, 500 h, 500 i. As illustrated inFIG. 3C, side 73 of connector 70 is oriented labially, and side 71 ofconnector 70 is oriented lingually to be in biased engagement withlabial side 64 of tooth 62, tip 69 of tooth 62, and a portion of lingualside 66 of tooth 62 proximate tip 69. As illustrated in FIG. 3C,anterior flange 74 may extend a distance T from the centerline of tooth62 to posterior end 75 of anterior flange 74. Anterior flange 74 definessides 78, 79, and channel 81 is defined by side 78 to receive one ormore teeth, such as tooth 62, as illustrated. In variousimplementations, T may generally range from about 10 mm to about 30 mm.In various implementations, T may be about 12 mm. In variousimplementations, T may be either constant or may vary along the lengthof anterior flange 74.

Anterior flange 74 engages tongue tip 113 in various ways to stimulatethe hypoglossal nerve. As illustrated, tongue tip 113 of tongue 100 isin contact with posterior end 75 of anterior flange 74 and with side 78of anterior flange 74, which may cause positioning of the tongue downand anteriorly resulting in dilation of the pharyngeal airway andconcomitant increased respiratory performance.

FIG. 4A illustrates a portion of connector 142 of exemplary dentalappliance 140 in engagement with, for example, tooth 147 selected fromtooth 500 e, 500 f, 500 g, 500 h, 500 i, 500 j. Side 141 of connector142 is biased against labial side 148 of tooth 147 to the tip 149 oftooth 147, in this implementation, with tip 149 not covered by connector142.

FIG. 4B illustrates an implementation of dental appliance 150 includinga portion of connector 170 in engagement with, for example, tooth 162selected from tooth 500 e, 500 f, 500 g, 500 h, 500 i, 500 j. Asillustrated in FIG. 4B, side 173 of connector 170 is oriented labially,and side 171 of connector 170 is in biased engagement with labial side164 of tooth 162, tip 169 of tooth 162, and a portion of lingual side166 of tooth 162 proximate tip 169. Accordingly, tip 169 of tooth 162 iscovered by connector 170, in this implementation.

FIGS. 5A and 5C illustrates connector 70. Side 71 of connector 70, whichis biased against labial sides of anterior mandibular teeth, such astooth 107, conforms to the shapes of the anterior mandibular teeth, inthis implementation. As illustrated, side 71 of connector 70 includesrecesses 77 within which sides of the anterior mandibular teeth arereceived, such as labial side 108 of tooth 107, and side 71 of connector70 includes crests 76 that intrude into interstices between teeth. Asillustrated in FIG. 5C, connector 70 is of generally constant widthalong its length. Anterior flange 74 including posterior end 75 extendsalong mesial portions of connector 70, as illustrated. Anterior flange74 may extend posteriorly along connector 70 to a greater or lesserextent, in various other implementations.

FIGS. 5B and 5D illustrates connector 170 of dental appliance 150. Side171 of connector 170, which is biased against labial sides of anteriormandibular teeth, such labial side 164 of tooth 162, is generally smoothso as not to conforms to the specific shapes of the anterior mandibularteeth, in this implementation. As illustrated in FIG. 5C, connector 170is of varying width along its length that generally conforms to theshape of labial anterior portions of the user's mouth.

FIGS. 6A, 6B, and 6C illustrate an exemplary implementation of a dentalappliance 200. The dental appliance 200, as illustrated in FIGS. 6A and6B, is formed as a generally U-shaped member, the curved portions of the“U” extends around anterior portions of the user's mouth and thestraight portions of the “U” extend from the anterior toward theposterior of the mouth. Dental appliance 200 defines a buccal-labialside 212 that is generally oriented toward the cheeks and/or lips of theuser and a lingual side 214 that is generally oriented toward the user'stongue 300 when the dental appliance 200 is positioned in the mouth. Asillustrated in FIGS. 6A, 6B and 6C, exemplary dental appliance 200includes bodies 220, 222 connected to one another by connector 270.Anterior segment 216 of dental appliance 200 is positioned anteriorlyand posterior ends 215, 217 are positioned posteriorly mesiallysymmetrically with respect to one another in the mouth when dentalappliance 200 is received in the mouth of the user, in thisimplementation.

As illustrated in FIGS. 6A and 6B, bodies 220, 222 of exemplary dentalappliance 200 include occlusal pads 240, 242 bonded to bite pads 230,232, respectively. As illustrated, side 246 of occlusal pad 240 isbonded to side 236 of bite pad 230, and side 248 of occlusal pad 242 isbonded to side 238 of bite pad 232. Sides 236, 238, of bite pads 230,232 are generally oriented opposite to sides 237, 239 of bite pads 230,232, respectively, and sides 246, 248 of occlusal pads 240, 242 aregenerally oriented opposite to sides 247, 249 of occlusal pads 240, 242,in this implementation.

In the implementation of FIGS. 6A and 6B, occlusal pads 240, 242 defineocclusal pad channels 256, 258 in sides 247, 249, respectively. Occlusalpad channels 256, 258 may removably engage posterior maxillary teeth onopposing sides of the maxillae to removably attach dental appliance 200to the maxillary teeth. For example, occlusal pad channels 256, 258 ofdental appliance 200 may engage the maxillary 1^(st) bicuspid, maxillary2^(nd) bicuspid, maxillary 1^(st) molar, maxillary 2^(nd) molar, andmaxillary 3^(rd) molar (when present) on the left side and right side,respectively. Occlusal pad channels 256, 258 may be fit to the user'steeth in order to conform to the shape of the user's teeth includinginterstices between the user's teeth. The dental appliance may beremovably attached to various maxillary teeth, in variousimplementations.

When occlusal pad channels 256, 258 of occlusal pads 240, 242 areengaged with maxillary teeth, sides 247, 249 of occlusal pads 240, 242are oriented toward the maxillary gums and sides 237, 239 of bite pads230, 232 are oriented toward the mandibular teeth. The mandibular teethmay engage with sides 237, 239 of bodies 220, 222, respectively, whichmay include treads and so forth, and may otherwise be generally adaptedto engage the mandibular teeth.

As illustrated in FIGS. 6A and 6B, body 220 and body 222 are connectedto one another by connector 270. Side 271 of connector 270 is orientedlingually and side 273 of connector 270 is oriented buccal labially, asillustrated, when dental appliance 200 is positioned in the mouth.Connector 270 generally passes about buccal-labial potions of theanterior maxillary teeth of the user with side 271 of connector 270biased variously against the anterior maxillary teeth and anteriormaxillary gums, and side 273 of connector 270 is oriented labially (i.e.toward the lips), in this implementation.

As illustrated in FIGS. 6A, 6B, flanges 290, 292 extend forth in lingualmesial directions from lingual side 214 of dental appliance 200generally along the straight portions of the “U,” as illustrated inFIGS. 6A and 6B. Flange 290 extends lingually toward the mandible frombody 220 with edge 291 of flange 290 being of a scalloped configuration,as illustrated. Similarly, as illustrated, flange 292 extends linguallytoward the mandible from body 222 with edge 293 of flange 292 being of ascalloped configuration. When exemplary implementation of dentalappliance 200 is engaged with the maxillary teeth, sides 298, 299 offlanges 290, 292 are oriented generally toward the palate while avoidingcontact with the palate, while sides 296, 297 of flanges 290, 292 areoriented toward the mandible while avoiding contact with the lingualfrenulum root of the tongue, or other anatomical structures axiallybelow the side of the tongue.

In various implementations, flanges 290, 292 may be of unitaryconstruction with the occlusal pads 240, 242, so that flanges 290, 292are formed of the same material as occlusal pads 240, 242. In variousimplementations, flanges 290, 292 may be of unitary construction withthe bite pads 230, 232, so that flanges 290, 292 are formed of the samematerial as bite pads 230, 232. Flanges 290, 292 may extend forth fromvarious portions of lingual side 214 of dental appliance 200 includingvarious portions of body 220, 222, in various implementations.

As illustrated in FIG. 6C, body 220 of dental appliance 200 is engagedwith maxillary tooth 306, where maxillary tooth 306 may be selected frommaxillary teeth 305 including maxillary 1^(st) bicuspid, maxillary2^(nd) bicuspid, maxillary 1^(st) molar, maxillary 2^(nd) molar, andmaxillary 3^(rd) molar (when present) on the left side. Mandibular tooth216, as illustrated, is biased against side 237 of bite pad 230, andmandibular tooth 216 is opposite maxillary tooth 306. Mandibular toothmay be, for example, one of 500 a, 500 b, 500 c, 500 d (see FIG. 2). Asillustrated in FIG. 6C, body 220 includes bite pad 230, occlusal pad240, and flange 290. Bite pad 230 is secured to occlusal pad 240, andmaxillary tooth 306 is received in occlusal channel 256 of occlusal pad240, as illustrated.

Edge 291 of flange 290 may be biased against at least portions of side310 of the portion of the tongue 300, for example, adjacent maxillarytooth 306. Edge 293 of flange 292 may be biased against portions of side310 of tongue 300, as illustrated in FIG. 6C. Sides 310, 312 of tongue300 may be generally adjacent mandibular teeth from the mandibular1^(st) bicuspid to the mandibular 3^(rd) molar (when present) along theleft and right sides, respectively. The biasing of edges 291, 293 offlanges 290, 292 against at least portions of sides 310, 312,respectively, of tongue 300 may stimulate the hypoglossal nerve causingcontraction of the genioglossus so that the tongue is positionedanteriorly and lowered toward the mandible, which may result in dilationof the pharyngeal airway and, thus, increased respiratory performance.

FIGS. 7A and 7B illustrated implementations of dental appliances 400,450 having various exemplary arrangements of flanges 432, 442, 462, 472,482 that interact with the tongue, inter alia, to stimulate thehypoglossal nerve in order to cause forward contraction of thegenioglossus that may result in an increased oropharynx opening in thethroat. Other arrangements or numbers of flanges, such as flanges 74,90, 92, 290, 292, 432, 442, 462, 472, 482, may be disposed in variousways about the dental appliance, for example, to stimulate thehypoglossal nerve of the tongue at various locations by contacting thetongue in order to prompt forward contraction of the genioglossus, invarious implementations.

FIG. 7A illustrates portions of dental appliance 400 including flange432 with edge 433, flange 438 with flange 439, and flange 442 with edge443. Flanges 432, 438, 442 are connected with other structures of dentalappliance 400 that have been omitted from FIG. 7A for clarity ofexplanation. As illustrated in FIG. 7A, edge 433 of flange 432 biasesagainst side 410 of tongue 405 to stimulate the hypoglossal nervegenerally proximate teeth 500 b, 500 c. Edge 439 of flange 438 biasesagainst side 412 of tongue 405 to stimulate the hypoglossal nerve, asillustrated, generally proximate teeth 500 l, 500 m. Edge 443 of flange442 biases against tongue tip 413 of tongue 405 generally proximateteeth 500 g, 500 h (the mandibular central incisors) to stimulate thehypoglossal nerve. Note that edges 433, 439, 443 have a curvature thatconforms generally to the corresponding curvature of the tongue.

FIG. 7B illustrates portions of dental appliance 450 including flange462 with edge 463, flange 472 with edge 473, flange 482 with edge 483,flange 486 with edge 487, and flange 492 with edge 493. As illustrated,flanges 462, 472, 482 486, 492 are connected with other structures ofdental appliance 450 that have been omitted from FIG. 7B for clarity ofexplanation. Edges 463, 473, 487, 493 of flanges 462, 472, 486, 492 biasagainst corresponding sides 456, 457, 459, 461 of tongue 455 tostimulate the hypoglossal nerve at these locations, and edge 483 offlange 482 biases against tongue tip 458 to stimulate the hypoglossalnerve proximate tongue tip 458. Side 456 is proximate teeth 500 a, 500b, side 457 is proximate teeth 500 c, 500 d, side 458 is proximate teeth500 f, 500 g, 500 h, 500 i, side 459 is proximate teeth 500 k, 500 l,and side 461 is proximate teeth 500 m, 500 n, as illustrated. Flanges462 and 472 are, for example, in spaced relation to one another as areflanges 486, 492, in this implementation. Note that edges 463, 473, 487,493 have a concave shape so that only portions of edges 463, 473, 487,493 contact tongue 455, in this implementation.

FIG. 9 illustrates portions of dental appliance 600 including base 620attached removably to tooth 601, with tooth 601 being a mandibular toothselected, for example, from 500 a, 500 b, 500 c, 500 d. Flange 690, asillustrated in FIG. 9, extends forth from lingual side of dentalappliance by length 693 to impress edge 691 of flange 690 into tongue609 a length 697. Length 693 is measured from lingual side 602 of tooth601 to edge 691 of flange 690, as illustrated. Length 697, asillustrated, may be sufficient to compress the transversus linguae 613,the styoglossus 611, or both the transversus linguae 613 and thestyoglossus 611 that, in turn, causes forward contraction of thegenioglossus 617. Tongue 609 is illustrated in cross-section at alocation along the along the anterior-posterior dimension. Dependingupon the anterior-posterior positioning of flange 690, edge 691 mayimpress into the hyoglossus 615 a length, such as length 697, sufficientto compress the hyoglossus 615 that, in turn, causes forward contractionof the genioglossus 617. Note that the hypoglossal nerve innervates thetransversus linguae 613, the styoglossus 611, the hyoglossus, 615 andthe genioglossus 617, so that the transversus linguae 613, thestyoglossus 611, the hyoglossus 615, and the genioglossus 617communicate with one another via the hypoglossal nerve and by physicalinterconnections, as illustrated in FIG. 9. Accordingly, impressment offlange 690 onto one or more of the transversus linguae 613, thestyoglossus 611, the hyoglossus 615, and the genioglossus 617 may causepositioning of the tongue down and anteriorly resulting in dilation ofthe pharyngeal airway and concomitant increased respiratory performance.The flange 690 has length, such as length 693, to impress into one ormore of the transversus linguae 613, the styoglossus 611, the hyoglossus615, and the genioglossus 617 to cause positioning of the tongue downand anteriorly resulting in dilation of the pharyngeal airway andconcomitant increased respiratory performance, in variousimplementations.

As illustrated in FIG. 9, base 620 includes bite pad 630 and occlusalpad 640 bonded to one another. Flange 690 is formed unitarily withocclusal pad 640, in this implementation. The length 699 between sides696, 698 is greatest where flange 690 emerges from occlusal pad 640gradually diminishing toward edge 691 with edge 691 being rounded.Flange 690 has a bell shape, in this implementation. Otherimplementations of the flange, such as flange 690, may be bell shapedand skewed. Still other implementation of the flange, such as flange690, may have a constant length between sides, such as length 699, tohave a generally constant cross-sectional shape such as a rectangularcross-sectional shape. Length 699 is less than the length between side641 and side 643 of occlusal pad 640, as illustrated.

Experiment 1

Various commercially available dental appliances and modifications ofthe commercially available dental appliances were tested in vivo inExperiment 1. These tests are labeled R1-R5 and are described asfollows:

-   -   R1—No dental appliance    -   R2—Wedge mouthpiece with reverse 4 mm in the back of mouth and 2        mm in the front, inside portion is missing, no contact with the        tongue    -   R3—Under Armour® boil and bite    -   R4—Altered Under Armour® boil and bite with the inside portion        missing, no contact with the tongue    -   R5—Similar to R2 with a reverse 4 mm in the back of the mouth        and 2 mm in the front and instead of a slope there is a        noticeable 1 mm step in the middle of the increase from front to        back, lingual portion of dental appliance is missing, no contact        with the tongue.

Two exemplary configurations of the dental apparatus according to thepresent disclosure were tested in vivo in Experiment 1. These arelabeled and described as follows:

-   -   DG proto*—generally similar to the exemplary dental appliance 10        including flanges 90, 92 generally posterior on dental appliance        10. Does not include anterior flange 74.    -   DG tong*—generally similar to the exemplary dental appliance 10        including flanges 90, 92 generally located on posterior portions        of dental appliance 10. Includes anterior flange 74 that may        push the tongue down slightly thereby placing the tongue in        optimal position to increase airway opening.        -   *the numbers 1 & 2 refer to specific tests.

In Experiment 1, the subject ran 5 minutes on a treadmill with thedental appliance inserted in the subject's mouth. Then, the respiratoryrate of the subject was measured using a True Max metabolic cartmanufactured by Parvo Medics, Inc., Sandy, Utah immediately followingthe 5 minute run on the treadmill, The same subject tested each of thedental appliances. The tests occurred on different days, so that thesubject had sufficient time to recover physically between tests. Thesubject was, of course, in good physical condition. Results for thevarious dental appliances are illustrated in FIG. 8

As illustrated in FIG. 8, the measured respiratory rates for the subjectusing dental appliances R1-R5 ranged from about 38 BPM to about 42 BPM(Breaths Per Minute). The measured respiratory rate for the subjectusing dental appliance DG prototype were 29.8 BPM and 31.3 BPM Themeasured respiratory rate for the subject using dental appliance DG tongwere 28.6 BPM and 32.3 BPM

Thus, these experimental results indicate that respiratory ratedecreased by as much as 13 BPM when dental appliances DG prototype andDG tong were used by the subject from the respiratory rates exhibitedwhen the subject either used no dental appliances R1 or when the subjectused dental appliances R2-R5. The decrease in respiratory rate usingdental appliances DG prototype and DG tong is indicative of increasedrespiratory performance resulting from use of dental appliances DGprototype and DG tong

In operation, the dental appliance, such as dental appliance 10, 140,150, 200, 450, may be received in the mouth of the user in removableattachment to one or more teeth, such as tooth 500 a, 500 b, 500 c, 500d, 500 k, 500 l, 500 m, 500 n, or various maxillary teeth such asmaxillary molars and maxillary bicuspids. The dental appliance may beremovably attached to various combinations of teeth in variousimplementations.

With the dental appliance removably attached within the mouth of a user,one or more flanges, such as flange 74, 90, 92, 290, 292, 432, 438, 442,462, 472, 482, 486, 492, 690 may contact the tongue, such as tongue 100,300, 405, 455, 609 to stimulate the hypoglossal nerve of the tongue atvarious locations in order to prompt forward contraction of thegenioglossus. Forward contraction of the genioglossus may result indilation of the pharyngeal airway and concomitant increased respiratoryperformance. The hypoglossal nerve may be stimulated at variouslocations around the tongue including the side of the tongue andproximate the tip of the tongue, and flanges may be provided at variouslocations about the dental appliance to so stimulate the hypoglossalnerve by contact with the tongue.

A bumper, such as bumper 80, may stimulate the lip or lips to provokepursed lip breathing that may increase respiratory performance. Wedgeshaped bite pads, such as bite pads 30, 32, may position the jaw in waysthat increase respiratory performance. Various stimulations of the lips,the hypoglossal nerve, positioning of the jaw, and combinations thereofby the dental appliance may increase respiratory performance by other asyet unrecognized physiologic responses.

The foregoing discussion along with the Figures discloses and describesvarious exemplary implementations. These implementations are not meantto limit the scope of coverage, but, instead, to assist in understandingthe context of the language used in this specification and in theclaims. The Abstract is presented to meet requirements of 37 C.F.R. §1.72(b) only. This Abstract is not intended to identify key elements ofthe apparatus and methods disclosed herein or to delineate the scope ofthis disclosure. Upon study of this disclosure and the exemplaryimplementations herein, one of ordinary skill in the art may readilyrecognize that various changes, modifications and variations can be madethereto without departing from the spirit and scope of the inventions asdefined in the following claims.

The invention claimed is:
 1. A method, comprising the steps of:attaching removably a dental appliance to teeth within a mouth of auser, the dental appliance having a first occlusal pad, a secondocclusal pad, and a connector extending between said first and secondocclusal pads, a lingual side oriented toward a tongue, a flangeextending from said lingual side of each of said occlusal pads, at leastone support formed within said flange; stimulating nerves of the tongueby touching a most mesial portion of the lingual side of the dentalappliance with the tongue; and the step of stimulating nerves of thetongue prompting forward contraction of the tongue positioning thetongue anteriorly and mandibularly downward thereby dilating apharyngeal airway.
 2. The method of claim 1, further comprising the stepof: displacing a mandible forward thereby increasing the pharyngealairway by biasing of posterior—anterior sloped bite pads of the dentalappliance between axially opposing teeth.
 3. The method of claim 1,wherein the most mesial portion of the lingual side of the dentalappliance forms said flange.
 4. The method of claim 3, wherein theflange forms an edge that bounds the most mesial portion of the lingualside of the dental appliance.
 5. The method of claim 3, wherein theflange is scalloped.
 6. The method of claim 1, wherein only nerves ofthe side of the tongue anterior of a first molar are stimulated.
 7. Themethod of claim 6, wherein the nerves of the side of the tonguegenerally between the first molar and first bicuspid are stimulated. 8.The method of claim 1, further comprising the step of: promoting pursedlip breathing by contacting lips with a bumper on a labial side ofanterior portions of the dental appliance.
 9. The method of claim 1,further comprising the step of: stimulating nerves proximate a tip ofthe tongue thereby positioning the tongue anteriorly and downward towarda mandible using an anterior flange that extends lingually from anteriorportions of the dental appliance.
 10. The method of claim 1, wherein oneor more mandibular teeth are secured to the dental appliance to attachthe dental appliance within the mouth.
 11. The method of claim 1,wherein one or more maxillary teeth are secured to the dental applianceto attach the dental appliance within the mouth.
 12. A method,comprising the steps of: attaching removably a dental appliance to teethwithin a mouth of a user, the dental appliance having a first occlusalpad, a second occlusal pad, and a connector extending therebetween, alingual side oriented toward a tongue, a flange extending from saidfirst and second occlusal pads on said lingual side, and at least onesupport embedded in each flange; stimulating nerves of the tongue bytouching the tongue generally between a first molar and a first bicuspidon a side of a mesial line and the mesial line with a most mesialsurface of the lingual side of the dental appliance; and wherein thestep of stimulating nerves of the tongue prompting forward contractionof the tongue thereby positioning the tongue anteriorly and mandibularlydownward.
 13. The method of claim 12, further comprising the step of:shifting a mandible of the user anteriorly by biasing wedge-shaped bitepads of the dental appliance between axially opposing posterior teeth.14. The method of claim 12, the step of stimulating nerves of a side ofthe tongue includes at least portions of the most mesial surfacestimulating nerves of a muscle selected from a group consisting of anextrinsic genioglossus, an intrinsic verticalis, and a transversuslinguae.
 15. The method of claim 12, wherein the side of the tongue iscontinuously stimulated by the most mesial surface between the firstmolar and the first bicuspid.
 16. The method of claim 12, wherein themost mesial surface of the lingual side of the dental appliance formsthe flange extending at least between the first molar and the firstbicuspid.
 17. A method, comprising the steps of: attaching removably adental appliance to teeth within a mouth of a user, the dental appliancehaving a first occlusal pad, a second occlusal pad, and a connectorextending between said first and second occlusal pads, a lingual sideoriented toward a tongue a flange extending from said lingual side ofeach of said occlusal pads, at least one support formed within saidflange; stimulating nerves of the tongue by touching the tongueproximate a tongue tip of the tongue with an anterior flange thatextends lingually from anterior portions of the dental appliance whenthe dental appliance is attached within the mouth; and wherein the stepof stimulating nerves of the tongue prompting forward contraction of thetongue positioning the tongue anteriorly and mandibularly downwardthereby dilating a pharyngeal airway.
 18. The method of claim 17,further comprising the step of: stimulating nerves of the tongue bytouching the tongue generally between a first molar and a first bicuspidon a side of a mesial line with a most mesial surface of the lingualside of the dental appliance.
 19. The method of claim 18, wherein themost mesial surface comprises portions of the lingual side locatedclosest to the mesial line.
 20. The method of claim 17, furthercomprising the step of: shifting a mandible of the user forward bybiasing wedge-shaped bite pads of the dental appliance between axiallyopposing posterior teeth.